The iLux and Mechanical Meibomian Gland Expression for the Treatment of Moderate and Severe Meibomian Gland Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds.
研究概览
简要总结
Summary:
Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).
Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT <10 s, who were randomized 1:1 to ILux® or MMGE.
详细描述
Meibomian glands (MG) are responsible for the secretion of lipids (meibum) into the ocular surface and have a protective role for tear film against evaporation1-4; therefore, Meibomian Gland Dysfunction (MGD) is associated with evaporative dry eye (EDE). Hyperkeratinization and hyperviscosity occur in dysfunctions with low MG expressibility, low meibum quality and eyelid margin inflammation. Finally, atrophy and dropout of MGs in some cases could appear MGD is a prevalent dry eye disorder (DED) with an estimated prevalence range between 3.5% and 70%1,10-13, it constitutes the primary underlying pathology within the EDE subtype. On top of this, MGD is chronic and progressive, so it is imperative to identify clinical approaches that can effectively target this underlying condition.
Treatment of MGD often involves artificial lubricants, topical lipid supplements, lid hygiene, warm compression or heat application, supplement omega-3, topical and systemic antibiotics against Demodex mite infestation, and steroids.
Mechanical management involves debridement-scaling of the line of Marx and lowers lid margin21, and other methods for mechanical manual expression in alignment with the concept that optimal treatment of MGD requires the employment of some forms of evacuating MGs contents.
Eyelid thermal pulsation devices combine the application of heat at the appropriate temperature to the palpebral surface with simultaneous compression of the glands to evacuate their contents, and have been shown to improve signs and symptoms over 12 months in cases of severe meibomian obstruction.
More recently, the ILux® MGD Treatment System (Alcon, FortWorth, TX, USA) is an eyelid thermal pulsation system that includes a single-use patient interface device and a portable battery-powered instrument that simultaneously applies localized heat and compression to treat MGD and showed significant improvements in MG function between one and four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years
- •A history of self-reported dry eye symptoms for two months prior to study enrollment,
- •Diagnosis of MGD Low delivery type, with mechanism obstructive and non- cicatricial with scores as follows: Ocular Surface Disease Index (OSDI) questionnaire ≥ 13, Non-Invasive Tear break-up time (NIBUT) lower than 10 seconds (The Sirius anterior segment analyzer (CSO, Florence, Italy).
- •Meibomian gland scores (MGS) lower than 15.
排除标准
- •A history of ocular surgery
- •Allergic conjunctivitis
- •Seborrheic dermatitis
- •Psoriasis
- •Punctal plugs or previous punctal cautery
- •Anterior or demodex blepharitis
- •Cicatricial lid margin disease
- •Ocular injury or trauma
- •Chemical burns
- •Limbal stem cell deficiency
- •Active ocular infection or non-dry eye inflammation
- •Aqueous-deficient dry eye
- •Irregular cornea
- •Lid abnormalities and systemic disease conditions
- •Medications that cause dry eye.
研究组 & 干预措施
iLUX Treatment System
The eyelid tissue is warmed by light energy produced by LEDs in the Instrument and transmitted through the precise Outer Pad. The Inner Pad and Eye Shield block light transmission directly into the eye during a treatment temperature sensor and measure the inner and outer eyelid temperatures to maintain a meibum melt temperature of 38-42°C.
干预措施: iLUX Treatment System (Device)
Mechanical Meibomian Gland Expression
- Local heat using an electrical warming mask for 5 minutes.
- Using a standardized device (Arita Meibomian Gland Compressor, Katena) to apply a standard force to individual glands
干预措施: iLUX Treatment System (Device)
结局指标
主要结局
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds.
时间窗: 1 year
NIBUT measured by SIRIUS device in seconds.
Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS).
时间窗: 1 year
Using a Meibomian Gland Evaluator (MGE 1000) to grade a total score for 15 meibomian glands in the lower eyelid evaluated in 3 areas: nasal (5 glands), medial (5 glands), and temporal (5 glands) expressed \& graded from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid).
次要结局
未报告次要终点